PAPERS

Subgroup analysis of a randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure

WT Abraham, K Nademanee, K Volosin, S Krueger, S Neelagaru, N Raval, O Obel, S Weiner, M Wish, P Carson, K Ellenbogen, R Bourge, M Parides, RP Chiacchierini, R Goldsmith, S Goldstein, Y Mika, D Burkhoff and A Kadish
J Card Fail 2011;17:710-717

BACKGROUND: Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the absolute refractory period intended to improve contraction. We previously tested the safety and efficacy of CCM in 428 NYHA functional class III/IV heart failure patients with EF greater than or equal to 25% were significant predictors of increased efficacy. In this subgroup (comprising 97 OMT and 109 CCM patients, approximately 48% of the entire population) VAT increased by 0.10 plus-minus 2.36 in CCM versus -0.54 plus-minus 1.83 mL kg(-1) min(-1) in OMT (P = .03) and pVO(2) increased by 0.34 plus-minus 3.11 in CCM versus -0.97 plus-minus 2.31 (P = .001) at 24 weeks compared with baseline; 44% of CCM versus 23% of OMT subjects showed improvement of  more than or equal to 1 class in NYHA functional class (P = .002), and 59% of CCM versus 42% of OMT subjects showed a more than or equal to 10-point reduction in Minnesota Living with Heart Failure Questionnaire (P = .01). All of these findings were similar to those seen at 50 weeks. CONCLUSIONS: The results of this retrospective hypothesis-generating analysis indicate that CCM significantly improves objective parameters of exercise tolerance in a subgroup of patients characterized by normal QRS duration, NYHA functional class III symptoms, and EF >25%.

 

Tags: , , , , , , , , , , , , , , , , ,

Download Full Paper

« Back to Papers